Effect of High Dose Fish Oil Supplementation After Recent Heart Attack Using Magnetic Resonance Imaging

Myocardial Infarction Clinical Trial

— OmegaREMODEL  

Official title:

Prognostic, Anti-arrhythmic, and Ventricular Remodeling Effects of High Dose Fish Oil in Patients With a Recent Myocardial Infarction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00729430
• Other study ID #: 591
• Secondary ID: R01HL091157-01
• Status: Completed
• Phase: Phase 3
• First received: August 4, 2008
• Last updated: May 25, 2017
• Start date: August 2008
• Est. completion date: July 2014

Study information

• Verified date: May 2017
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Doctors use magnetic resonance imaging (MRI) to obtain detailed pictures of the inside of the body. This study will evaluate a new MRI technique in people who have recently had a heart attack. Researchers will also examine the effect of fish oil supplementation on heart health in study participants.

Description:

A new MRI technique to examine the heart was recently developed. In this study, researchers will use this new technique to evaluate the heart in people who have recently had a heart attack to determine whether a specific pattern of heart muscle damage is related to sudden cardiac death. This fatal condition, also known as cardiac arrest, occurs when the heart abruptly stops pumping blood to the body, resulting in loss of consciousness, absence of pulse, and a stop in breathing. The most common cause of sudden cardiac death is a heart attack.

In addition to evaluating the new heart MRI technique, this study will also examine the effects of fish oil supplementation in people who have recently had a heart attack. Recent research has shown that omega-3 fatty acids, commonly found in fish oil, may be beneficial for people with heart conditions. Lastly, the study will determine whether specific biomarkers and genetic factors can help predict the likelihood of a person dying from sudden cardiac death after previously experiencing a heart attack.

Apart from studying the likelihood of sudden cardiac death, This study will measure the change in structure and pumping function of the heart (known as ventricular remodeling) and this study will determine if the high dose of fish oil treatment will result in an improvement of the heart.

This study will enroll people who have had a heart attack in the 2 to 4 weeks before study entry. At a baseline study visit, participants will undergo an MRI of their heart and complete an exercise stress test on a treadmill. A blood sample will be collected, and women will provide a urine sample for a pregnancy test. Questionnaires asking about diet, medical history, and emotions will also be completed. Participants will then be randomly assigned to receive either fish oil supplements or placebo on a daily basis for 6 months. Every 2 to 3 months, study researchers will call participants to check on their health and progress. At a study visit at Month 6, participants will undergo repeat baseline testing. After this visit, study researchers will call participants every 6 months for 3 years to follow up on participants' health status.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 358
• Est. completion date: July 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Experienced a heart attack in the 2 to 4 weeks before study entry

• Lives in the greater Boston area or adjacent regions (within a 50-mile radius of Boston)

Exclusion Criteria:

• Unable to undergo an MRI because of metallic implants (e.g., pacemakers, an implantable cardioverter defibrillator [AICD]) at time of study entry

• Active cancer or any other terminal illness with an expected survival rate of less than 6 months after study entry

• Significant kidney dysfunction with a glomerular filtration rate (GFR) of less than 60 mL/min in the 2 weeks before study entry

• Inability to follow study procedures

• Pregnant

• Hemodynamic instability

• Urgent clinical need for a pacemaker or AICD

• Inaccessibility of medical records

Related Conditions & MeSH terms

• Death, Sudden
• Death, Sudden, Cardiac
• Infarction
• Myocardial Infarction

Intervention

Drug:
• Omega-3 Fatty Acids (Fish Oil Supplements)
4 grams of omega-3 fatty acids taken orally once per day for 6 months
• Placebo
Placebo tablets taken orally once per day for 6 months

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital, Shapiro Cardiovascular Center	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	GlaxoSmithKline, National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Heydari B, Abdullah S, Pottala JV, Shah R, Abbasi S, Mandry D, Francis SA, Lumish H, Ghoshhajra BB, Hoffmann U, Appelbaum E, Feng JH, Blankstein R, Steigner M, McConnell JP, Harris W, Antman EM, Jerosch-Herold M, Kwong RY. Effect of Omega-3 Acid Ethyl Est — View Citation

Yan AT, Shayne AJ, Brown KA, Gupta SN, Chan CW, Luu TM, Di Carli MF, Reynolds HG, Stevenson WG, Kwong RY. Characterization of the peri-infarct zone by contrast-enhanced cardiac magnetic resonance imaging is a powerful predictor of post-myocardial infarction mortality. Circulation. 2006 Jul 4;114(1):32-9. Epub 2006 Jun 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of Omega-3 Fatty Acids on Adverse Left Ventricular Remodeling	Measured as change in left ventricular end-systolic volume indexed to body surface area from baseline to post-treatment (6-months)	Before and after study treatments
Secondary	Effect of Omega-3 Fatty Acids on Non-Infarct Myocardial Fibrosis	Measured as change in myocardial extracellular volume fraction of non-infarcted myocardium from baseline to post-treatment (6-months)	Measured in the 3-year follow-up period after participant's last study visit
Secondary	Effect of Omega-3 Fatty Acids on Left Ventricular Ejection Fraction	Measured as change in left ventricular ejection fraction from baseline to post-treatment (6-months)	Measured in the 3-year follow-up period after participant's last study visit
Secondary	Effect of Omega-3 Fatty Acids on Infarct Size	Measured as change in infarct size from baseline to post-treatment (6-months)	Measured in the 3-year follow-up period after participant's last study visit